Trial · NCT01251315
The Effects of a Glutathione Precursor (FT061452),on Serum and Intracellular Glutathione Levels
NCT01251315, Phase 1, Completed, Charles Drew University of Medicine and Science; results first posted 2014-03-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Effects of a Glutathione Precursor (FT061452),on Serum and Intracellular Glutathione Levels. Trials, record NCT01251315. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01251315
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effects of a Glutathione Precursor (FT061452),on Serum and Intracellular Glutathione Levels
- NCT number
- NCT01251315
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 24 participants, actual
- Lead sponsor
- Charles Drew University of Medicine and Science
- Conditions
- Oxidative Stress
- Interventions
- Placebo low dose, N Acetyl cysteine, 600mg (low dose), Proimmune 200 (FT061452) 3000mg low dose, Placebo (high dose), N Acetyl cysteine, 1200mg (high dose), FT061452, 6000mg high dose
- First posted
- 2010-12-01
- Last updated
- 2014-04-14
- Results first posted
- 2014-03-17
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Intracellular Glutathione Level | 6 hours | Mean intracellular glutathione level every 2 hour |
| Secondary | Augmentation Index | Baseline and 6 hours | Augmentation index (%) is defined as the percentage of the central pulse pressure which is attributed to the reflected pulse wave and, therefore, reflects the degree to which central arterial pressure is augmented by wave reflection" if appropriate augmentation index has been shown to be a predictor of adverse cardiovascular events in a high risk patient populations,higher augmentation index is associated with target organ damage. Absolute change of augmentation index from baseline to 6 hours will be estimated for the analysis. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Augmentation Index | Baseline and 6 hours | percentage of the central pulse pressure | MEAN | |
| PRIMARY | Intracellular Glutathione Level | 6 hours | Intention-to-treat | µmol/L | MEAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Augmentation Index | Placebo-A | Baseline | 20 | Standard Deviation 5.0 | percentage of the central pulse pressure |
| Augmentation Index | N Acetyl Cysteine-A | Baseline | 19.8 | Standard Deviation 10.2 | percentage of the central pulse pressure |
| Augmentation Index | Proimmune 200-A | Baseline | 28.5 | Standard Deviation 12.7 | percentage of the central pulse pressure |
| Augmentation Index | Placebo-B | Baseline | 27 | Standard Deviation 10.8 | percentage of the central pulse pressure |
| Augmentation Index | N Acetyl Cysteine-B | Baseline | 20.3 | Standard Deviation 11.9 | percentage of the central pulse pressure |
| Augmentation Index | Proimmune 200-B | Baseline | 26.5 | Standard Deviation 6.0 | percentage of the central pulse pressure |
| Augmentation Index | Placebo-A | 6 hour | 11.3 | Standard Deviation 8.4 | percentage of the central pulse pressure |
| Augmentation Index | N Acetyl Cysteine-A | 6 hour | 11.3 | Standard Deviation 6.9 | percentage of the central pulse pressure |
| Augmentation Index | Proimmune 200-A | 6 hour | 19 | Standard Deviation 10.4 | percentage of the central pulse pressure |
| Augmentation Index | Placebo-B | 6 hour | 24.8 | Standard Deviation 5.3 | percentage of the central pulse pressure |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo Low Dose Group, Given Oral as a Single Dose | 4 | |
| Overall Study | STARTED | N Acetyl Cysteine (Low Dose, 600mg Oral as a Single Dose) | 4 | |
| Overall Study | STARTED | Proimmune 200 (Low Dose, 3000 mg Oral as a Single Dose) | 4 | |
| Overall Study | STARTED | Placebo High Dose Group, Given Oral as a Single Dose | 4 | |
| Overall Study | STARTED | N Acetyl Cysteine (High Dose, 1200 mg Oral as a Single Dose) | 4 | |
| Overall Study | STARTED | Proimmune 200 (High Dose, 6000 mg Oral as a Single Dose) | 4 | |
| Overall Study | COMPLETED | Placebo Low Dose Group, Given Oral as a Single Dose | 4 | |
| Overall Study | COMPLETED | N Acetyl Cysteine (Low Dose, 600mg Oral as a Single Dose) | 4 | |
| Overall Study | COMPLETED | Proimmune 200 (Low Dose, 3000 mg Oral as a Single Dose) | 4 | |
| Overall Study | COMPLETED | Placebo High Dose Group, Given Oral as a Single Dose | 4 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo-A | ||
| Total, all-cause mortality | N Acetyl Cysteine-A | ||
| Total, all-cause mortality | Proimmune 200-A | ||
| Total, all-cause mortality | Placebo-B | ||
| Total, all-cause mortality | N Acetyl Cysteine-B | ||
| Total, all-cause mortality | Proimmune 200-B | ||
| Total, other adverse events | Placebo-A | 0 | 4 |
| Total, other adverse events | N Acetyl Cysteine-A | 0 | 4 |
| Total, other adverse events | Proimmune 200-A | 0 | 4 |
| Total, other adverse events | Placebo-B | 0 | 4 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01251315
GET https://conductscience.org/api/trials/v1/NCT01251315/results?page=2